Aptose Reports Year End 2024 Results and Corporate Highlights
Aptose Biosciences (NASDAQ: APTO, TSX: APS) reported its 2024 year-end results and corporate updates, highlighting progress in its tuspetinib (TUS)-based triple drug therapy for acute myeloid leukemia (AML). The TUSCANY Phase 1/2 trial, combining TUS with venetoclax and azacitidine, has shown promising results with complete remissions in TP53-mutated and FLT3-wildtype AML patients.
The company secured approximately $37 million in financing during 2024, including a $10 million loan from Hanmi Pharmaceutical. In March 2025, Hanmi converted $1.5 million of debt into 409,063 common shares. Aptose also entered a CRADA with the National Cancer Institute for clinical development collaboration.
Financial results show a net loss of $25.4 million for 2024, down from $51.2 million in 2023. Research and development expenses decreased to $15.1 million from $36.8 million. The company's cash position of $6.7 million is expected to fund operations until April 2025.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) ha riportato i risultati di fine anno 2024 e aggiornamenti aziendali, evidenziando i progressi nella sua terapia farmacologica tripla a base di tuspetinib (TUS) per la leucemia mieloide acuta (AML). Il trial TUSCANY di Fase 1/2, che combina TUS con venetoclax e azacitidina, ha mostrato risultati promettenti con remissioni complete nei pazienti con AML mutati TP53 e wildtype FLT3.
L'azienda ha ottenuto circa 37 milioni di dollari in finanziamenti durante il 2024, inclusi un prestito di 10 milioni di dollari da Hanmi Pharmaceutical. Nel marzo 2025, Hanmi ha convertito 1,5 milioni di dollari di debito in 409.063 azioni ordinarie. Aptose ha anche stipulato un CRADA con il National Cancer Institute per una collaborazione nello sviluppo clinico.
I risultati finanziari mostrano una perdita netta di 25,4 milioni di dollari per il 2024, in calo rispetto ai 51,2 milioni di dollari del 2023. Le spese per ricerca e sviluppo sono diminuite a 15,1 milioni di dollari rispetto ai 36,8 milioni. La posizione di cassa dell'azienda di 6,7 milioni di dollari è prevista per finanziare le operazioni fino ad aprile 2025.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) informó sobre sus resultados de fin de año 2024 y actualizaciones corporativas, destacando los avances en su terapia de triple medicamento basada en tuspetinib (TUS) para la leucemia mieloide aguda (AML). El ensayo TUSCANY de Fase 1/2, que combina TUS con venetoclax y azacitidina, ha mostrado resultados prometedores con remisiones completas en pacientes con AML mutados TP53 y wildtype FLT3.
La empresa aseguró aproximadamente 37 millones de dólares en financiamiento durante 2024, incluyendo un préstamo de 10 millones de dólares de Hanmi Pharmaceutical. En marzo de 2025, Hanmi convirtió 1,5 millones de dólares de deuda en 409.063 acciones comunes. Aptose también firmó un CRADA con el Instituto Nacional del Cáncer para una colaboración en el desarrollo clínico.
Los resultados financieros muestran una pérdida neta de 25,4 millones de dólares para 2024, en comparación con 51,2 millones de dólares en 2023. Los gastos de investigación y desarrollo disminuyeron a 15,1 millones de dólares desde 36,8 millones. La posición de efectivo de la empresa de 6,7 millones de dólares se espera que financie las operaciones hasta abril de 2025.
Aptose Biosciences (NASDAQ: APTO, TSX: APS)는 2024년 연말 결과 및 기업 업데이트를 보고하며, 급성 골수성 백혈병(AML)을 위한 tuspetinib (TUS) 기반의 삼중 약물 요법에서의 진행 상황을 강조했습니다. TUS와 벤토클락스, 아자시티딘을 결합한 TUSCANY 1/2상 시험은 TP53 변이 및 FLT3 정상형 AML 환자에서 완전 관해를 보이며 유망한 결과를 나타냈습니다.
회사는 2024년 동안 약 3,700만 달러의 자금을 확보했으며, 여기에는 Hanmi Pharmaceutical로부터의 1천만 달러 대출이 포함됩니다. 2025년 3월, Hanmi는 150만 달러의 부채를 409,063주 보통주로 전환했습니다. Aptose는 또한 임상 개발 협력을 위해 국립암연구소(National Cancer Institute)와 CRADA를 체결했습니다.
재무 결과는 2024년에 2,540만 달러의 순손실을 기록했으며, 이는 2023년의 5,120만 달러에서 감소한 수치입니다. 연구 및 개발 비용은 3,680만 달러에서 1,510만 달러로 감소했습니다. 회사의 현금 보유액 670만 달러는 2025년 4월까지 운영 자금을 지원할 것으로 예상됩니다.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) a rapporté ses résultats de fin d'année 2024 et des mises à jour d'entreprise, mettant en avant les progrès de sa thérapie médicamenteuse triple à base de tuspetinib (TUS) pour la leucémie myéloïde aiguë (LMA). L'essai TUSCANY de Phase 1/2, combinant TUS avec le vénotoclax et l'azacitidine, a montré des résultats prometteurs avec des rémissions complètes chez les patients atteints de LMA mutés TP53 et wildtype FLT3.
L'entreprise a sécurisé environ 37 millions de dollars de financement pendant 2024, y compris un prêt de 10 millions de dollars de Hanmi Pharmaceutical. En mars 2025, Hanmi a converti 1,5 million de dollars de dettes en 409.063 actions ordinaires. Aptose a également signé un CRADA avec le National Cancer Institute pour une collaboration en développement clinique.
Les résultats financiers montrent une perte nette de 25,4 millions de dollars pour 2024, en baisse par rapport à 51,2 millions de dollars en 2023. Les dépenses de recherche et développement ont diminué à 15,1 millions de dollars contre 36,8 millions. La position de trésorerie de l'entreprise de 6,7 millions de dollars devrait financer les opérations jusqu'en avril 2025.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) hat seine Jahresergebnisse 2024 und Unternehmensupdates veröffentlicht und dabei Fortschritte bei seiner tuspetinib (TUS)-basierten Dreifachtherapie für akute myeloische Leukämie (AML) hervorgehoben. Die TUSCANY Phase 1/2-Studie, die TUS mit Venetoclax und Azacitidin kombiniert, hat vielversprechende Ergebnisse mit vollständigen Remissionen bei TP53-mutierten und FLT3-wildtyp AML-Patienten gezeigt.
Das Unternehmen sicherte sich im Jahr 2024 etwa 37 Millionen Dollar an Finanzierungen, darunter ein Darlehen über 10 Millionen Dollar von Hanmi Pharmaceutical. Im März 2025 wandelte Hanmi 1,5 Millionen Dollar Schulden in 409.063 Stammaktien um. Aptose trat auch in eine CRADA mit dem National Cancer Institute für eine klinische Entwicklungszusammenarbeit ein.
Die finanziellen Ergebnisse zeigen einen Nettoverlust von 25,4 Millionen Dollar für 2024, ein Rückgang von 51,2 Millionen Dollar im Jahr 2023. Die Forschungs- und Entwicklungskosten sanken von 36,8 Millionen Dollar auf 15,1 Millionen Dollar. Die Liquiditätsposition des Unternehmens von 6,7 Millionen Dollar wird voraussichtlich die Betriebe bis April 2025 finanzieren.
- Complete remissions achieved in difficult-to-treat AML patients in TUSCANY trial
- Successful debt conversion agreement with Hanmi Pharmaceutical
- Significant reduction in net loss by $25.8 million year-over-year
- Secured $37 million in financing during 2024
- R&D expenses decreased by $21.7 million
- cash runway until April 2025
- Non-compliance with Nasdaq's $2.5 million shareholders equity requirement
- Reduced R&D activities and lower headcount in 2024
- Cash position decreased to $6.7 million
Insights
Aptose's year-end results reveal a substantially improved financial position with net losses decreasing by
The company's financing activities in 2024 totaling
While regaining Nasdaq minimum bid compliance is positive, the company remains non-compliant with the
The clinical data for tuspetinib (TUS) in the TUSCANY trial shows promising early signals in difficult-to-treat AML populations. The achievement of complete remissions (CRs) in TP53-mutated and FLT3-wildtype AML patients is particularly noteworthy, as these represent significant unmet medical needs in AML treatment. The triplet therapy combining TUS+VEN+AZA appears to be well-tolerated, with no significant safety concerns reported, including the absence of prolonged myelosuppression in patients achieving remission - a common complication in AML therapies.
The successful dose escalation from 40mg to 80mg TUS in the triplet therapy following safety committee approval indicates a favorable therapeutic window. The CSRC's decision to escalate dosing suggests confidence in both safety and preliminary efficacy signals. The robust safety database from previous studies (>170 patients across single-agent and doublet trials) provides solid foundational evidence supporting this triplet approach.
The CRADA with the National Cancer Institute represents significant validation, enabling tuspetinib's evaluation in the myeloMATCH trials across molecularly defined AML and MDS populations. This expands the drug's potential utility while leveraging NCI resources. The clinical strategy of positioning tuspetinib as a "mutation agnostic" therapy differentiates it from other kinase inhibitors that target specific mutations, potentially broadening its market opportunity if successful. Early data supports this hypothesis, but larger cohorts are needed to confirm these preliminary signals.
Tuspetinib Triple Drug Frontline Therapy Advancing in TUSCANY Clinical Trial
Results to Date Highlight TUS Potential as an Ideal Third Drug to Include in AML Triplet Therapy
Aptose Signs Debt Conversion Agreement with Hanmi
SAN DIEGO and TORONTO, March 28, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing a tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), today announced financial results for the year ended December 31, 2024, and provided a corporate update.
"During 2024 and into 2025, we continue to advance our lead investigational drug tuspetinib in combination with venetoclax (VEN) and azacitidine (AZA) for frontline treatment of newly diagnosed acute myeloid leukemia (AML),” said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. “Tuspetinib brings favorable safety and broad activity across AML genetic subtypes to the TUS+VEN+AZA triplet therapy, which already has achieved complete remissions (CRs) in difficult-to-treat and underserved TP53-mutated/CK AML and FLT3-wildtype AML patients in our ongoing TUSCANY trial. We look forward to sharing more data as the trial evolves.”
Key Corporate Highlights
- Tuspetinib Phase 1/2 TUSCANY Trial Well Under Way with Responses Noted - Tuspetinib based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 trial with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations (mutation agnostic triplet frontline therapy), including FLT3-wildtype AML. This activity differentiates TUS from other drugs in development. In January 2025, Aptose announced initiation of dosing in the first TUSCANY trial cohort with the starting dose of 40 mg TUS in combination with standard-of-care doses of VEN+AZA. At 40 mg TUS, the triplet therapy achieved complete remissions (CRs) in difficult-to-treat TP53-muated AML and FLT3-wildtype AML patients, including a measurable residual disease (MRD) negative remission (press release here). In February 2025, amid the promising early results and favorable safety from patients treated at the 40 mg dose level, the Cohort Safety Review Committee (CSRC) monitoring the TUSCANY trial approved escalating to 80 mg TUS in the triplet therapy (press release here). Subjects have now begun treatment at the 80 mg TUS dose level of the triplet therapy and further recruitment is under way. No significant safety concerns have been reported to date, including no prolonged myelosuppression of subjects in remission. This TUS+VEN+AZA triplet therapy study in newly diagnosed AML was supported with robust safety and efficacy data from the TUS single agent dose escalation study and the TUS+VEN doublet APTIVATE study in relapsed or refractory (R/R) AML, both of which were completed during 2024 after treating more than 170 patients.
- Financing Activity – During 2024, Aptose completed several financings for a total of approximately
$37 million to support the TUS-based TUS+VEN+HMA triplet therapy development for AML. This included a$10 million loan Facility Agreement with Hanmi Pharmaceutical Co. Ltd. (“Hanmi”). Subsequently in March 2025, Hanmi and Aptose executed a Debt Conversion Agreement to convert a portion of the debt into equity, subject to Hanmi owning no more than19.99% of the issued and outstanding common shares of Aptose. Therefore, an amount of$1.5 million has been converted into 409,063 common shares as of this date. Beyond the$10 million , Aptose and Hanmi are negotiating a new tuspetinib co-development collaboration agreement intended to provide additional funding to accelerate clinical development of tuspetinib. Aptose licensed tuspetinib from Hanmi Pharmaceutical in November 2021. - Aptose Signs CRADA with NCI – In December, Aptose announced that it entered into a Cooperative Research and Development Agreement (“CRADA”) with the National Cancer Institute (NCI), part of the National Institutes of Health (press release here). Under the CRADA, the NCI and Aptose will collaborate on the clinical development of TUS, an inhibitor of key signaling kinases involved in myeloid malignancies, in the NCI Cancer Therapy Evaluation Program (CTEP) sponsored myeloMATCH trials employing combinations of targeted therapy for the treatment of molecularly defined AML and myelodysplastic syndromes (MDS) populations. These trials will be conducted by NCI's National Clinical Trials Network (NCTN), with the participation of the NCI Community Oncology Research Program (NCORP) in the U.S. and Canada.
- Aptose Meets Nasdaq Minimum Bid Compliance – Earlier this month, Aptose announced that it received a written notification from the Listing Qualifications Department of The Nasdaq Stock Market, LLC notifying the Company that it is in compliance with Nasdaq’s minimum bid price requirement (press release here). On March 14, 2025, Nasdaq confirmed that, for ten consecutive business days, the closing bid price of the Company’s common shares has been
$1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2). Separately, Aptose is not in compliance with the$2.5 million shareholders equity requirement and is operating under an exception granted by the Nasdaq Hearing Panel, which provides Aptose additional time to regain compliance, although there is no assurance that the Company will successfully achieve full compliance with the Nasdaq shareholders equity requirement.
Completed and Planned Value-Creating Milestones
2024 Accomplishments
- Completed
$10 million loan from Hanmi as Advance on Collaboration - Completed
$8 million S-1 financing - Executed CRADA with NCI MyeloMATCH for tuspetinib in AML/MDS
- Initiated dosing of TUS+VEN+AZA triplet therapy in newly diagnosed AML patients in TUSCANY trial
- ASH: Reported CR/Safety from APTIVATE TUS and TUS+VEN trial
- ASH: Reported dosing accrual from TUS+VEN+AZA triplet therapy trial
2025: 1H
- Demonstrated safety and efficacy with 40mg TUS+VEN+AZA in triplet therapy trial
- Dosing 80mg TUS in TUS+VEN+AZA dose cohort in triplet therapy trial
- Executed Debt Conversion agreement with Hanmi
- Expect to report CR/MRD/Safety data from TUS+VEN+AZA triplet therapy trial
- Expect to execute Hanmi/Aptose Collaboration
- EHA2025 Congress - Report maturing data readout from TUS+VEN+AZA triplet therapy trial
2025: 2H
- Select optimal TUS doses for TUS+VEN+HMA triplet therapy Ph 2/3 pivotal trials
- Prepare for Ph 2 portion of Ph 2 / Ph 3 pivotal program
- American Society of Hematology (ASH) Update
FINANCIAL RESULTS OF OPERATIONS | ||||||
Aptose Biosciences Inc. | ||||||
Statements of Operations Data | ||||||
(unaudited) | ||||||
($ in thousands, except for share and per share data) | ||||||
Year ended | ||||||
December 31, | ||||||
2024 | 2023 | |||||
Expenses: | ||||||
Research and development | $ | 15,103 | $ | 36,765 | ||
General and administrative | 11,154 | 15,591 | ||||
Operating expenses | 26,257 | 52,356 | ||||
Other income, net | 827 | 1,149 | ||||
Net loss | $ | (25,430 | ) | $ | (51,207 | ) |
Net loss per share, basic and diluted | $ | (36.38 | ) | $ | (227.43 | ) |
Weighted average number of common shares outstanding used in computing net loss per share, basic and diluted | 698,980 | 225,154 | ||||
Net loss for the year ended December 31, 2024 decreased by
Aptose Biosciences Inc. | |||||||
Balance Sheet Data | |||||||
(unaudited) | |||||||
($ in thousands) | |||||||
December 31, | December 31, | ||||||
2024 | 2023 | ||||||
Cash, cash equivalents and restricted cash equivalents | $ | 6,707 | $ | 9,252 | |||
Working capital | 5,071 | (3,375 | ) | ||||
Total assets | 10,127 | 12,989 | |||||
Long-term liabilities | 10,211 | 621 | |||||
Accumulated deficit | (540,967 | ) | (515,537 | ) | |||
Shareholders’ deficit | (4,543 | ) | (2,901 | ) | |||
- Total cash, cash equivalents and restricted cash equivalents as of December 31, 2024, were
$6.7 million . Based on current operations, the Company expects that cash on hand and available capital provides the Company with sufficient resources to fund planned Company operations including research and development until April 2025. - As of March 21, 2025, we had 2,552,429 Common Shares issued and outstanding. In addition, there were 39,219 Common Shares issuable upon the exercise of outstanding stock options and there were 1,267,585 Common Shares issuable upon the exercise of the outstanding warrants.
RESEARCH AND DEVELOPMENT EXPENSES
The research and development expenses for the years ended December 31, 2024 and 2023 were as follows:
Year ended | |||||
December 31, | |||||
(in thousands) | 2024 | 2023 | |||
Program costs – Tuspetinib | $ | 9,606 | $ | 24,925 | |
Program costs – Luxeptinib | 422 | 3,510 | |||
Program costs – APTO-253 | (19 | ) | 40 | ||
Personnel related expenses | 4,735 | 6,878 | |||
Stock-based compensation | 346 | 1,373 | |||
Depreciation of equipment | 13 | 39 | |||
Total | $ | 15,103 | $ | 36,765 | |
Research and development expenses decreased by
- Program costs for tuspetinib were
$9.6 million for the year ended December 31, 2024, compared with$24.9 million for the comparable period in 2023. The lower program costs for tuspetinib in the current year were due to reduced activity in our APTIVATE clinical trial, reduced manufacturing costs, and related expenses. In the comparable period in 2023, Tuspetinib program costs included the healthy volunteer study, which was completed in the same year. - Program costs for luxeptinib decreased by approximately
$3.1 million primarily due to lower clinical trial and manufacturing activities. - Program costs for APTO-253 decreased by approximately
$59 thousand . This reduction was due to the Company’s decision to discontinue further development of APTO-253. - Personnel-related expenses decreased by
$2.1M due to lower headcount 2024. - Stock-based compensation decreased by approximately
$1.0 million in the year ended December 31, 2024, primarily due to stock options granted with lower grant date fair values when compared to the options granted in the prior period, coupled with option forfeitures recorded in the current year.
About Aptose
Aptose Biosciences is a clinical-stage biotechnology company committed to developing precision medicines addressing unmet medical needs in oncology, with an initial focus on hematology. The Company's small molecule cancer therapeutics pipeline includes products designed to provide single agent efficacy and to enhance the efficacy of other anti-cancer therapies and regimens without overlapping toxicities. The Company’s lead clinical-stage compound tuspetinib (TUS), is an oral kinase inhibitor that has demonstrated activity as a monotherapy and in combination therapy in patients with relapsed or refractory acute myeloid leukemia (AML) and is being developed as a frontline triplet therapy in newly diagnosed AML. For more information, please visit www.aptose.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, statements regarding the Company’s clinical development plans, the clinical potential, anti-cancer activity, therapeutic potential and applications and safety profile of tuspetinib, clinical trials, the enrollment in clinical trials and the data therefrom, the submission of a compliance plan to Nasdaq and available options to regain compliance, upcoming milestones and presentation of additional data, financing activities, expectations regarding capital available to the Company to fund planned Company operations, maintenance of the Nasdaq and TSX listings, use of proceeds from financings, the conversion of debt into equity contemplated by the Debt Conversion Agreement entered into with Hanmi, the negotiation of a co-development collaboration agreement with Hanmi, the collaboration with the NCI for the clinical development of tuspetinib and statements relating to the Company’s plans, objectives, expectations and intentions and other statements including words such as “continue”, “expect”, “intend”, “will”, “hope” “should”, “would”, “may”, “potential” and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to obtain the capital required for research and operations; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market and economic conditions; unexpected manufacturing defects, the evolving regulatory and political landscape and the funding of government programs and other risks detailed from time-to-time in our ongoing current reports, quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward- looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.
For further information, please contact:
Aptose Biosciences Inc.
Susan Pietropaolo
Corporate Communications & Investor Relations
201-923-2049
spietropaolo@aptose.com
